Patients May Be Compensated for Lower Limb Amputations and Ketoacidosis with Invokana

More than 28 million adults in the United States live with type 2 diabetes, according to a 2017 National Diabetes Statistics Report.  For many of these individuals, the prospect of lowering their blood glucose level (blood sugar) with a medication such as Invokana (canagliflozin) is an attractive opportunity.  Unfortunately for some of the patients who have taken Invokana, serious side effects have occurred.  Some unexpected side effects have led to the need for leg, foot, or toe amputations.  Others have resulted in a serious condition known as ketoacidosis (high levels of acid in the blood) developing, which led to hospitalization. 

Approved in 2013 for treatment of type 2 diabetes, Invokana was the first SGLT2 (solium-glucose cotransporter-2) drug in the U.S.  Taken once a day, the drug works with the kidneys to help lower blood sugar through urination.  Invokana is manufactured by Janssen Pharmaceutical, a subsidiary of Johnson & Johnson.  Invokamet and Invokamet XR are a combination of Invokana and Metformin into one pill.

Amputation Risk

In May 2016, the U.S. Food & Drug Administration (FDA) issued a drug safety communication based on interim clinical trial results for Invokana showing an increased amputation risk.  In May 2017, the FDA issued another safety announcement requiring new warnings for Invokana including their Boxed Warning, the strictest label requirement that the FDA can place on prescription drugs associated with a significant hazard.

These FDA actions followed the final results from two trials which showed that canagliflozin doubled the risk of lower- extremity amputations when it was compared to the use of placebos over a one-year period.

• CANVAS (Canagliflozin Cardiovascular Assessment Study) – the risk of amputation was:
  • 9 out of every 1,000 patients treated with canagliflozin
  • 8 out of every 1,000 patients treated with a placebo
• CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints) – the risk of amputation was:
  • 5 out of every 1,000 patients treated with canagliflozin
  • 2 out of every 1,000 patients treated with a placebo

The September 2017 edition of Medpage Today reported that a number of doctors and hospital-affiliated medical groups are taking patients off of Invokana following these study results.  The article quotes Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, where half of his heart patients also have diabetes.  Nissen says that the clinical trial outcomes have made him “uncomfortable prescribing [canagliflozin] in view of the amputation risk”.

A patient who is taking Invokana should watch for any warning signs including foot or leg pain, tenderness, sores, ulcers, or infections.

Risk of Ketoacidosis

Invokana can also cause a side effect known as ketoacidosis (too much acid in the blood).  In December 2015, the FDA warned that patients who are taking SGLT2 inhibitors should stop taking the drug and seek medical attention if they are experiencing the warning signs of ketoacidosis.  These symptoms include:

• Nausea
• Vomiting
• Abdominal pain
• Tiredness
• Trouble breathing. 

After identifying a number of patients who developed diabetic ketoacidosis, the FDA also added new warnings and precautions about this condition to the labels of all SGLT2 inhibitors .

Other Serious Side Effects

The FDA reports that other side effects of Invokana include:

• Low blood pressure
• Kidney problems
• High potassium in the blood
• Severe urinary tract infections which can lead to life- threatening blood infections and kidney infections
• Low blood sugar when combined with other diabetes prescriptions
• Yeast infections
• Bone breaks
• Increased cholesterol

Does Your Injury Qualify for Compensation?

The manufacturer of Invokana may be held liable for failure to warn physicians and the public about serious complications. 

Did you take Invokana, and can you reply ‘yes’ to any of these questions?

• Did you suffer a below-the-knee amputation?
• Did you suffer ketoacidosis which developed prior to December 2015 (when the label warnings changed)?
• Were you hospitalized with another severe adverse condition after taking Invokana?

If so, you may be entitled to compensation.